Site Start-Up Specialist

Fortrea; Madrid; Híbrido; EUR 42.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Flexible work arrangements

Professional growth opportunities

Exposure to cutting-edge clinicals

Descripción de la vacante

Fortrea is seeking a Site Start-Up Specialist to coordinate site activation, manage essential documents, and ensure timely regulatory submissions. You will work with the FSPx team and regulatory authorities to accelerate clinical trials.

The ideal candidate will have a life sciences background, 2+ years in clinical research, and strong organizational and communication skills. This role offers flexible work arrangements and exposure to cutting-edge projects in a collaborative environment.

Formación

• Degree in life sciences or allied health field.
• Minimum 2 years in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP, RA, IRB/IEC regulations, and start-up processes.
• Ability to adapt patient informed consent forms to local/protocol needs.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving and communication skills.

Responsabilidades

• Serve as primary contact for investigative sites during start-up and maintenance.
• Collect and organize documents for regulatory submissions (EC/IRB/Third Party/RA).
• Ensure compliance with ICH/GCP and sponsor requirements.
• Prepare and submit regulatory documents incl. country forms and ICFs.
• Track submission timelines and address delays proactively.
• Collaborate with vendors, clinical teams, and regulatory authorities.
• Keep documentation audit-ready and systems updated.
• Assist in site contracts and budgets negotiations if applicable.
• Provide mentorship and training to new staff.

Conocimientos

Regulatory submissions

ICH/GCP knowledge

Project coordination

Communication skills

Documentation management

Regulatory authority liaison

Microsoft Office

Educación

Life sciences degree or allied health certification

Herramientas

Document management systems

Descripción del empleo

Join Our Team and Drive Clinical Research Success! At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster. In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.

Key Responsibilities

• Serve as the primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
• Track submission timelines and proactively address potential delays.
• Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
• Ensure all documentation is audit-ready and systems are consistently updated.
• Assist in the negotiation of site contracts and budgets, if applicable.
• Provide mentorship and training to new hires and less-experienced colleagues.

Required Qualifications

• University/College degree (life sciences preferred) or certification in a related allied health profession.
• Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
• Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

What We Offer

• Competitive salary and performance-based incentives.
• Flexible work arrangements (remote/hybrid options).
• Professional growth opportunities in a collaborative and innovative environment.
• The opportunity to work on cutting-edge clinical research projects.

At Fortrea, we're all about turning the "impossible" into 'I'm possible'. Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence.

Regardless of your role, we're all family, working together to achieve extraordinary results.

At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day. #LI-Remote #LI-Hybrid